Structured treatment interruptions

May 2008      View PDF      En español

Using an STI to help people with treatment fatigue

Simply put, treatment fatigue is when a person is “tired” of taking HIV medicines. This could be due to physical and/or emotional tiredness. For people who wish to stop their therapy for this reason, the data are somewhat conflicting. Various results show that some people can take a break without developing drug resistance, treatment failure or disease progression.

Several factors can help predict when a person may have a poorer outcome. These are:

• low CD4 count before starting therapy (below 200),
• high HIV level before starting therapy (above 55,000),
• poor control of virus while on therapy or other signs of drug resistance, and
• history of opportunistic infections (OIs).

There’s a significant difference between studies looking at a single STI than several of them. Numerous studies used CD4 counts and HIV levels as a guide for when to restart therapy after one STI. Nearly all were done in people who had reached undetectable HIV levels in the last 12 months or longer and CD4 counts above 350 in the last six months.

In most studies, at least 1 in 3 of the volunteers could stay off therapy for at least one year. The average time off therapy for the others ranged from 8–12 weeks. However, it should be noted that people who interrupted their treatment had large drops in their CD4 counts (on average dropping 50%). These decreases could be dangerous for people whose counts drop below 200, especially without proper preventive medicine for OIs.

Also, most studies were unable to consistently measure meaningful improvements in cholesterol and triglycerides in people on STIs. Dropout rates also tended to be higher among those on STIs. This indicates that STIs may actually be more difficult to manage than taking pills every day.

For people who wish to take a break from therapy because of treatment fatigue, certain guidelines can be followed. Because of higher risks for disease progression and OIs, careful monitoring by your doctor is critical during this time. People should check their health care programs (private and public) to ensure that the cost of additional lab tests would be covered if needed.

Testing your HIV level and CD4 count should be done before the STI and three months after it, if not sooner. You and your doctor should decide beforehand what factors would lead you to resume therapy. At a minimum, most people would recommend using the Federal Guidelines as a guide to restart therapy.

Also, drug resistance testing should be conducted when HIV levels are at their highest to determine whether a person should change to a new regimen when and if they resume treatment.

If your CD4 count was ever below 200, or you ever had an OI, it’s risky to take an STI to deal with treatment fatigue. People taking an STI usually see their CD4 counts fall fairly quickly to pre-treatment levels.

Some data show it may be safe for people who started therapy early in their infection to go off treatment safely. Swiss researchers looked at a group of people who began taking HIV drugs when their CD4 counts were over 500. These people had the option to stop or continue their HIV treatment. The researchers found no evidence of harm in the group of people who stopped treatment.

Other recent research suggests the opposite. An analysis from SMART found that people who restarted their HIV meds when the study was stopped continued to have higher rates of heart, liver and kidney problems compared to those on continuous treatment.

People who started HIV treatment with higher CD4 counts are the most likely to be able to stop HIV therapy safely. On average, roughly one-third to one-half of people treated early in their disease who participated in STI research have been able to stay off treatment for months. Some were able to control their HIV levels during the first STI; others needed two or three. For people who started HIV treatment somewhat later, the results have been less promising.

Reinvigorate the immune response

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Before starting third line therapy